Dietary Supplement Product Specification

111 70 f and the packaging and labeling for the finished packaged and labeled dietary.

Dietary supplement product specification. 21 cfr 111. Setting specifications is just one part of a quality system used in making dietary supplements. In june 2007 the fda published 21 cfr part 111 which established cgmp requirements for dietary supplements.

A dietary supplement s manufacturing specifications are a set of defined parameters and associated acceptance criteria that produce a finished product with the desired characteristics and quality. Tropiczone produces 2 performance mixtures that deliver a 37 protein 8 fat level providing an extra nutritional boost for the higher activity level and or breeding activity for these turtles. Additionally having good specifications ensures that the manufacturer is making the exact product specified and that there will be no surprises.

Usp documentary standards for dietary supplements are supported by chemical reference standards which are highly characterized specimens of dietary ingredients impurities and degradation products as well as usp compendial reagents and performance calibrators that are specified for use when conducting official usp nf tests and assays. Turtles kept in outdoor collections in large outside displays or in breeding situations can benefit from having an adjusted diet formulation. Establish specifications for components final sec.

When one sets a specification one must be able to verify the specification set is being met. 111 70 c labels and packaging final sec. Consistent with basic cgmp principles ensuring the quality of the dietary supplement product requires that the manufacturer establish precisely what it will produce specifications for its product how it will make the product processes and which process controls and tests it will use to ensure reliable reproducible results.

111 70 b in process production final sec. 111 70 e product that you receive from a supplier for packaging and labeling final sec.